arterial inflammation in cardiovascular disease
Conditions
Interventions
Subjects will be allocated to receive either 250 mg 3G10 or matching placebo,
which are both referred to as IMP.
Each subject will receive monthly intravenous injections for four months.
arterial inflammation
atherosclerosis
human monoclonal antibody
safety and tolerability
Sponsors
Athera Biotechnologies AB
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Provision of a signed written informed consent 2. Lp(a) above 50 mg/dL at screening 3. Male or female, >= 50 years of age at screening
Exclusion criteria
Exclusion criteria: 1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the result or the subject*s ability to participate in the study 2. Illness (including common colds) for the last 4 weeks before screening 3. Medical history of myocardial infarction (MI) or stroke within 12 months of screening 4. Ongoing or paroxysmal atrial fibrillation 5. Clinically overt heart failure 6. Hypertension defined as >=180/100 mmHg 7. Diabetes mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Change in TEM in monocytes isolated from treated subjects from baseline to visit 11 | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in tissue to background ratio (TBRmax) in common carotid arteries by fluorodeoxyglucose-positron emission tomography/computed tomography (18F-FDG PET/CT) from baseline to Visit 11 • Change in PWV (m/sec) assessed by Sphygmocor Xcel from baseline to Visit 11 • Safety and tolerability: number of AEs/SAEs, vital signs, physical examination, ECG and Laboratory assessments including haematology, clinical chemistry and immunogenicity. | — |
Countries
Sweden
Outcome results
None listed